Public engagement

There is a need to better communicate to the public and patients what is meant by the use of patient data in research, and to improve public engagement in discussions relating to policy decisions in this area. This was summed up in a quote from the Primary care Research Network: ‘A public campaign is needed to increase awareness of research as something that anyone in the UK could be involved with.

From a primary care perspective, if all patients were informed via their GP practice that their

record could be searched by appropriately qualified people to determine their eligibility for taking part in locally approved research (with an integrated opt-out), then that would speed finding participants.’ Participants at the PPI workshop felt that there is a need to inform not only patients, but the public more widely of the value of conducting research using patient data, while clearly articulating the safeguards that are in place and the opportunities to ‘opt-out’.

There is concern that often those involved in collecting patient data for clinical care (e.g. gPs) have been regarded as representing the patient viewpoint on this issue. In december 2009 the UK clinical Research collaboration (UKcRc) Subgroup on Public Awareness commissioned market research into the attitudes of patients and gPs on the use of patient data for research purposes, to potentially inform the foundation for their planned public awareness campaign.⁹⁷ One of the findings from this market research was the apparent lack of understanding of the value of research using patient data amongst Box 6.5 Case study: swine flu

In autumn 2009 the clinical Research Network fast-tracked studies into pandemic flu in response to the high national priority given to rapid research into the disease. This involved coordinating research in 314 NhS organisations across 640 research study sites, and driving through fast set-up times. As a result 57% of NhS research sites granted permission to start the study within two days of the Research ethics committee’s favourable opinion. The ability of NhS organisations to undertake rapid risk assessment was a key factor in the success of fast-tracking set-up of these studies. however, these studies also highlighted some of the inconsistencies in approach that remain in the system.

In one NIhR-funded study of swine flu conducted across several sites there was a need to send out questionnaires to patients who had been identified through anonymous datasets as eligible for inclusion in the study, to ask them whether they would like to consent to be involved. The involvement of the research team was required to print out address labels to send out the questionnaires. At one site the local Research ethics committee and university governance teams would not approve the research team having access to patient’s names and addresses before they had consented to take part in the study, and therefore a member of the clinical care team was required to take on this role. Although a member of the clinical care team agreed to undertake this activity, they were unable to complete it due to other (understandable) priorities.

consequently, for that site, instead of 200 questionnaires only 30 were sent out.

67 98 NhS connecting for health (2009). Using patient information in the NHS.

http://www.connectingforhealth.nhs.uk/engagement/public/consultations/hsreport.pdf

99 Royal Academy of engineering (2010). Privacy and prejudice: young people’s views on the development and use of electronic patient records.

http://www.raeng.org.uk/news/publications/list/reports/Privacy_and_Prejudice_ePR_views.pdf

100 New economics Foundation (2010). Who sees what? Exploring public views on personal electronic health records.

http://www.neweconomics.org/sites/neweconomics.org/files/Who_Sees_What.pdf

101 Wellcome Trust/University of Surrey (2006). Public attitudes to research governance: a qualitative study in a deliberative context.

http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtx038443.pdf 102 Medical Research council/Ipsos MORI (2007). The use of personal health information in medical research.

http://www.mrc.ac.uk/consumption/idcplg?IdcService=geT_FIle&dId=10983&ddocName=MRc003810&allowInterrupt=1 103 Academy of Medical Sciences (2006). Personal data for public good: using health information in medical research.

http://www.acmedsci.ac.uk/download.php?file=/images/publication/Personal.pdf

Box 6.6 Review of public engagement on use of patient data

The following reports have examined public views on the use of patient data. The individual reports should be referred to for detailed findings and information on the methods and samples used.

• NHS Connecting for Health. Using patient information in the NHS (2009).⁹⁸ This report found that the 96 participants were generally happy for their data to be used in research as long as anonymity was ensured and they were approached by someone they knew and trusted, such as their gP.

• Royal Academy of Engineering. Young people’s views on the development and use of Electronic Patient Records (2010).⁹⁹ Of 3,000 young people surveyed, most were not against the idea of anonymised data being used in medical research; 50% said that they would want to be asked for consent each time researchers used their anonymous record.

• New Economics Foundation. Exploring public views on personal electronic health records (October 2010).¹⁰⁰ Surveyed 6000 people and found: that 57% of adults and 67% of young people were enthusiastic about the benefits of switching to digital patient records; and that patient consent would be essential for using identifiable data for research.

• Wellcome Trust/University of Surrey. Public Attitudes to Research Governance (2006).¹⁰¹ Based on interviews and focus groups with 89 people; the report found

participants were willing to provide personal data for biomedical research providing its use had been explained to them. concerns remained over whether promises of anonymity and security could be fully relied on.

• MRC/Ipsos MORI. The Use of Personal Health Information in Medical Research (2007).¹⁰² Interviewed a sample of 2,106 UK adults and found that 69% were ‘likely’ to allow the data to be used for health research purposes.

• Academy of Medical Sciences. Personal data for public good: using health information in medical research (2006).¹⁰³ consulted with a wide range of patient representatives and found research using personal data was strongly supported. Public engagement was identified as one of the most important tasks in developing future arrangements for appropriate governance for the use of health information in health research.

the gPs who took part and their reluctance to facilitate access to patient data for research purposes. This was in marked contrast to the largely positive response from the patients on this issue.

Building on previous public engagement projects (Box 6.6), the UKcRc Subgroup on Public Awareness has initiated a programme to develop information materials that provide patients, the public and healthcare professionals with information about the use of

data in health research. We recommend that this work should continue and that the primary aim of these materials should be to provide information on what is meant by the use of data in health research and that this should inform decisions relating to ‘opt-out’. This programme will require the continued support of the UK health departments and should be integrated with our recommendation around improving public information on the core role of health research in the NhS (see Recommendation 1).

Recommendations

The legal framework around access to patient data is complicated involving UK legislation, case decisions, and an EU Directive. There are also a wide range of bodies involved in producing advice, each of which differs slightly in their focus, context and jurisdiction. This has resulted in conflicting interpretations of the regulation among stakeholders and a lack of clarity for patients and the public. Aspects of these problems are dealt with in our recommendations in Chapter 9, where we outline our proposal for a Health Research Agency. We urge the Government to evaluate progress on taking forward the recommendations from the Data Sharing Review (2008) and to ensure that the fundamental changes outlined within it are taken forward at pace, alongside the recommendations below. We recommend that:

Recommendation: The Ministry of Justice should undertake a thorough review of the UK data Protection Act to identify aspects that require clarification in relation to health research so as to inform the planned revisions to the eU data directive and subsequent amendments to the UK data Protection Act. As a priority, clear guidance on interpretation of these aspects of the Act should be provided for researchers and healthcare professionals by the Information commissioner in conjunction with the proposed new health Research Agency.

Recommendation: The role of caldicott guardians should not include the approval of research studies. Instead it should focus on facilitating the delivery of research studies for which

approvals relating to data have already been granted by other bodies.

Recommendation: As recommended in the data Sharing Review, a system should be

developed to allow approved researchers to work with healthcare providers to identify potential patients to be contacted about research studies in which they might wish to participate. The Information commissioner’s Office and the new health Research Agency should work with the health departments and other stakeholders to provide definitive guidance on this issue. This should state that researchers, or appropriate members of a research team such as research nurses, working on an ethically approved study should be considered part of a clinical care team for the purposes of accessing data to identify patients eligible to be contacted about research studies. The initial contact with these patients about a research study would be by a member of the patient’s clinical care team (i.e. not a researcher).

69

7.1 Introduction

Many research studies are underpinned by the use of human tissue to improve understanding of how diseases start and progress, and what keeps us healthy. The use of human tissue samples for research into, for example, cancer leads to improvements in diagnosis through the identification of biomarkers that help to develop new and more targeted treatments. Most clinical trials require tissue samples (e.g. blood, saliva, urine or tissue biopsies) from trial participants to be taken on a regular basis, to establish the impact of interventions. With the increasing role that genetic profiling will play in health research, access to tissue samples is an ever more vital element of research studies. examples of types of research involving human tissue include:

developing screening tests for different types of cancer, testing new treatments for conditions such as heart disease, and researching how stem cells could be used to treat conditions such as multiple sclerosis (see also Box 7.1).

In many instances tissue is removed during the course of regular clinical investigation or treatment, and there may be some tissue

remaining after the procedure that can be used for

research. At the PPI meeting we heard of patients’

desire for such tissue to be used in research:¹⁰⁴

‘A lady I knew who had had radiotherapy couldn’t undergo it a second time when her cancer recurred. She had to have her ovaries removed and was asked if she would donate them for research. It made losing them so much more bearable. It’s so important to have choice.’

Tissue for research can only be used with a person’s consent, unless it has been

adequately anonymised or the material is used for a specific research project approved by a recognised Research ethics committee (Rec).

A person may also give consent for their tissue to be used for research after their death. As in the case of the use of patient data (chapter 6), it is important that transparent processes are in place to support Principle 1 (safeguard participant well-being).

human embryos up to 14 days old can be used in research designed to increase knowledge about serious disease or its treatment. Such research is conducted primarily through the isolation of embryonic stem cells that are grown and transformed into specialised cells (e.g. muscle or nerve cells) through in vitro cell culture.